Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data (original) (raw)
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The British journal of general practice : the journal of the Royal College of General Practitioners, 2015
Trials show that oral anticoagulation therapy (OAT) substantially reduces thromboembolic events without an increase in major haemorrhagic events, but it is not known whether these results translate into routine practice. To estimate the current levels of control and adverse events in patients self-monitoring OAT, explore the factors that predict success, and determine whether the level of side effects reported from randomised controlled trials are translated to a non-selected population. Prospective cohort study in the UK. Participants were aged ≥18 years and registered with a GP. Main outcomes were the proportion of participants, over 12 months, who were still self-monitoring, had not experienced adverse events, and had achieved >80% of time in therapeutic range (TTR). In total, 296 participants were recruited; their median age was 61 years and 55.1% were male. Participants were predominately professional or held a university qualification (82.7%). At 12 months, 267 (90.2%) were...
British Journal of Haematology, 2006
Several studies suggest that patient self-management (PSM) may improve the quality of oral anticoagulation therapy as measured by time spent within the international normalised ratio (INR) target range. We performed a prospective randomised control trial to determine whether the improvement in quality of treatment afforded by PSM is greater than that achieved by patient self-testing (PST) alone. A total of 104 of 800 eligible patients aged 22-88 years (median ¼ 59AE8), attending our hospital anticoagulant clinic and receiving long-term warfarin for >8 months agreed to participate. Patients were randomised to PSM (n ¼ 55) or PST (n ¼ 49). Both groups measured their INR using the CoaguChek S every 2 weeks or more frequently if required, for a period of 6 months. Seventyseven of 104 (74%) patients completed the study (PSM ¼ 41 and PST ¼ 36). The 'drop out' rates for both groups were similar. There was no significant difference between the percentage time in target therapeutic range for PSM (69AE9%) and PST (71AE8%). Both groups combined showed a significant improvement over the previous 6 months (71AE0% vs. 62AE5%; P ¼ 0AE04). Changes in time within the therapeutic range in individual patients (+5AE86) also showed a significant difference. The quality of warfarin control in both PST and PSM may be superior to that achieved by conventional management in a specialised hospital anticoagulation clinic.
Self-monitoring of oral anticoagulation: does it work outside trial conditions?
Journal of Clinical Pathology, 2009
Background: Patient self-monitoring (PSM) of oral anticoagulation therapy (OAT) can improve anticoagulant control, but poor uptake and high dropout rates have prompted suggestions that PSM is suitable for only a minority of patients in the UK. Aims: To determine whether PSM could be a viable alternative to regular hospital anticoagulant clinic attendance, if offered from the start of treatment. Methods: 318 consecutive patients referred, for the first time, to an anticoagulation clinic were assessed for eligibility using established criteria. Patients electing for PSM attended training and, following successful assessment, performed a capillary blood INR every two weeks or more frequently if directed to do so by the anticoagulation clinic. Primary outcome measures were uptake of PSM and the percentage time in target therapeutic INR range (TIR) compared to patients electing for routine clinic care. Results: Of 318 patients referred for OAT, 188 were eligible for PSM. 84 (26%) elected to self-monitor, of whom 72 (23%) remained self-monitoring or had completed their course of treatment at the end of the audit. Self-monitoring patients had significantly better anticoagulant control than those receiving routine hospital anticoagulation clinic care (TIR 71% vs 60%, p = 0.003) and significantly less time outside critical limits, ie, INR ,1.5 or .5.0 (0.45% vs 2.04%, p = 0.008). Conclusions: Patients offered PSM from the start of treatment show increased uptake compared to previous UK studies and a level of oral anticoagulation control comparable to that reported in previous clinical trials.
Systematic review of studies of self-management of oral anticoagulation
2004
This work is aimed at assessing the evidence for the possible improvement of therapeutic control of anticoagulation, reduction of major bleedings, thromboembolism and improvement of treatment-related quality of life in patients with self-managed oral anticoagulation therapy versus oral anticoagulation patients on routine care. Randomised controlled trials (RCTs) were identified using the COCHRANE LIBRARY, MEDLINE and EMBASE from 1966 to 2003. RCTs were selected involving patients with oral anticoagulation, which were designed to compare a self-management group to a routine care group. Abstracts and keywords were screened and, in the case of potential inclusion, evaluated. We identified nine potentially relevant trials. Five were excluded for the following reasons: double publication, the patients involved performed only self-testing, or the results of the trial were only published as an abstract. Ultimately, four randomised controlled studies fulfilled the criteria for inclusion. Anticoagulation control: Statistical analysis was not possible because of the great variety of international normalised ratio measurements per patient between the different studies. Comparing the four studies, there was no difference in oral anticoagulation control between self-management care and management by a specialised anticoagulation clinic. In comparison with routine care by general practitioners, self-management care was found to be better. Major bleeding, arterial and venous thromboembolism: Data were available for all studies; however, the studies were either underpowered or obviously not valid and therefore not suitable for statistical analysis. Treatment-related quality of life: Data were available for two studies, which showed that self-management could clearly improve treatment-related quality of life. Patients' self-management can improve the quality of oral anticoagulation as an indirect parameter of a reduced risk for thromboembolic and bleeding complications. Self-management oral anticoagulation treatment is safe and improves treatment-related quality of life. Patients' self-management is safe and can improve the quality of anticoagulation control, however, no valid long term study has yet actually demonstrated reduction of bleeding and thromboembolic events.
International Journal of Cardiology, 2005
Aims: This document provides health care professionals involved in initiating and monitoring oral anticoagulation therapy with guidelines for the provision of safe and effective patient self-testing/patient self-management of oral anticoagulation. Methods and results: The consensus group has critically reviewed the literature and compared the results of usual care (UC) vs. anticoagulation clinic and patient self-management/patient self-testing (PSM/PST). The education and training of patients for self-monitoring are described, together with the suitability of patients, the effect on quality of life and cost-effectiveness. The consensus agrees that patient self-testing and patient self-management are effective methods of monitoring oral anticoagulation therapy, providing outcomes at least as good as, and possibly better than, those achieved with an anticoagulation clinic. All patients must be appropriately selected and trained. Currently available self-testing/self-management devices give INR results which are comparable with those obtained in laboratory testing. The most frequent testing frequency is weekly but lower frequency of testing can be justified based on institutional or patient conditions. Conclusions: The consensus agrees that there are several points in favour of PST/PSM, for example, a higher degree of medical safety, increased patient education, improved response to changes in lifestyle, increased independence for the patient and improved quality of life.
British Journal of Haematology, 2005
There is a limited evidence base for self-testing andmanagement for oral anticoagulation management. Available data suggest that these are credible models for a significant minority of patients if underpinned by structured training and follow-up. The guidelines presented are necessarily consensual and outline procedures for patient selection, training, product procurement, product maintenance, quality assurance procedures, dosage adjustment and clinical supervision. The costeffectiveness of these models remains to be elucidated within the UK. Further data on both health economic and clinical outcomes are required from UK based studies before widespread implementation of self-testing and management can be recommended on a wider scale.
SMART: self-management of anticoagulation, a randomised trial [ISRCTN19313375]
BMC family practice, 2003
Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR). The development of reliable near patient testing (NPT) systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, ...
Annals of Internal Medicine, 2011
The review concluded that patient self-testing/self-management was associated with significantly fewer deaths and thromboembolic events, without increasing bleeding complications, for patients requiring long-term anticoagulation with vitamin K antagonists compared with usual clinic care; however, the evidence was of moderate or low strength. The review had several limitations, suggesting its conclusions should be interpreted with caution. Authors' objectives To determine whether patient self-testing, alone or in combination with self-adjustment of doses (patient selfmanagement), is associated with a reduction in thromboembolic complications and all-cause mortality without an increase in major bleeding events, when compared with usual care. Searching MEDLINE was searched for studies published in English, in peer-reviewed journals, from 2005 to November 2010; search terms were reported. The Cochrane Central Register of Controlled Trials (CENTRAL) was also searched. References before 2005 were identified from a previous systematic review (see Other Publications of Related Interest). Reference lists of relevant articles were also examined to identify further studies.
BMC Cardiovascular Disorders, 2013
Background: The skills of patients on oral anticoagulants are critical for achieving good outcomes with this treatment. Self-management, or the capacity of patients to control their INR level and adjust their treatment, is an effective strategy of treatment. Capacity of patients to self manage is determined by a range of factors. The identification of these factors would improve the design of self management programmes and in turn increase the number of patients able to self-manage. The objective of our study is to identify those factors that determine the ability of patients on oral anticoagulant therapy to achieve self-management of their treatment. Design: This will be a three year quasi-experimental prospective study with a control group. 333 patients on anticoagulant therapy from five health centres of the Basque Health Service are to be followed up for a period of six months each after the intervention, to assess their ability to self-test and self-manage. The intervention will consist of a patient training programme involving the provision of information and practical training concerning their condition and its treatment, as well as how to use a portable blood coagulation monitoring device and adjust their anticoagulant dose. Discussion: The ease-of-use of this technique lead us to believe that self-management is feasible and will represent an innovative advance that should have a substantial impact on the quality of life of this patients and their families as well as on the health care provision systems.